Clinical Trials Directory

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UnknownNCT03163836

Concomitant Surgical Atrial Fibrillation Ablation in Double Valve Replacement

Impact of Concomitant Surgical Atrial Fibrillation Ablation in Patients Undergoing Double Valve Replacement

Status
Unknown
Phase
Study type
Observational
Enrollment
500 (estimated)
Sponsor
Guangzhou General Hospital of Guangzhou Military Command · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

Current European Society of Cardiology Guidelines recommend concomitant atrial fibrillation (AF) ablation for all symptomatic patients undergoing other cardiac surgeries, but the safety and potential benefits of concomitant atrial fibrillation (AF) ablation at the time of double valve replacement remains unexamined. A retrospective review of patients with AF who underwent double valve replacement with or without concomitant surgical ablation in our institute starting from April 2006.

Detailed description

Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months. Concomitant surgical AF ablation was offered to suitable patients as determined by the surgeon, and patients then decided whether to undergo the additional procedure. The operations were performed through median sternotomy and under cardiopulmonary bypass. The bipolar ablation clamp was positioned precisely around the pulmonary veins (PV) for bilateral circular ablation. After Marsh ligament cutting and cross-clamping the ascending aorta, the left atrial appendage was resected and left atrial cavity exposed through an incision behind the interatrial groove. Then, linear ablations were performed between the left and right inferior PVs, between the left and right superior PVs, between the left superior PV and the opening of the left atrial appendage, and between the line connecting bilateral inferior PVs and the mitral valve isthmus. Ablation at the right atrium was then performed. Briefly, the bipolar ablation clamp was positioned around the inferior vena cava (IVC) and right atrial appendage for circular ablation. An L-shaped incision was then made on the anterior wall of the right atrium and linear ablations were performed vertically from the incision to the interatrial groove and tricuspid annulus, to the ablation ring around the right atrial appendage, and from the superior vena cava to the ablation ring around the inferior vena cava. The left atrial appendage was always excluded by resection and the incision was closed with continuous running stitches. Temporary pacemakers were placed in all patients and activated when heart rate was less than 70 beats per minute.

Conditions

Interventions

TypeNameDescription
PROCEDUREdouble valve replacementAfter median sternotomy, cardiopulmonary bypass was established via bicaval and aortic cannulation. After cross-clamping of the aorta and cardioplegia, mitral and aortic replacement were performed. Supplementary procedures such tricuspid annuloplasty, ascending aorta replacement and coronary artery bypass grafting were performed as required. The left atrial appendage was excised to avoid thrombus formation.
PROCEDUREsurgical ablationBoth left and right atrial ablation were performed using a bi-polar radiofrequency ablation clamp.

Timeline

Start date
2006-04-01
Primary completion
2023-03-10
Completion
2023-03-10
First posted
2017-05-23
Last updated
2017-05-30

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03163836. Inclusion in this directory is not an endorsement.